Reporte zur Charge EVU6203

Symptomtext

itching and redness that spread; itching and redness that spread; tired and sleepy; tired and sleepy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EVU6203, Expiration date: Not reported), via an unspecified route of administration in left arm on 03Mar2021 at 12:45 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. Medical history included breaking out of shingles and had headache in Oct2020. No relevant family history was reported. There were no concomitant medications/other products reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: E63247, Expiration date: Not reported), via an unspecified route of administration in left arm on 27Jan2021 at 12:45 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization and experienced sore arm right away from the first shot; tired and sleepy; stressed; a little more tender at the injection site and the shot was given lower not in shoulder muscle but a little below it. No additional vaccines were administered on the same day of vaccination. The patient was not pregnant at the time of vaccination and didn't receive any other within 4 weeks prior to COVID vaccine. A couple of days after the second dose of vaccination in Mar2021, the patient had itching and redness which resembles like hives. The itching got worse and spread all over one arm, to all over another arm, to her leg and belly and across her tail, her rear end. In the beginning, she scratched it and went to work. It was mostly on her right arm on the outside and side of her right arm. Some of the spots are more intense red and some are a little bit round. Some of the areas look like a little ball of prickly stuff. When the redness starts to go away, it leaves places like scar where it looks like she was burned, and the rash was bumpy. She thought it was because she was nervous about getting the vaccination. She guessed that she was allergic to vaccine. The patient also had tiredness and sleepiness in Mar2021. The patient went to her doctor on 16Mar2021, and he thought it was something that she come in contact with her at home. She reported nothing was changed except having the second shot. After the second shot, she was not hurt and didn't feel any soreness at the injection site. The patient had been taking levocetirizine (XYZAL) 5 mg one tablet daily. For itching, she was taking hydroxyzine (ATARAX) 25 mg one by mouth as needed. It's been taken every 8 hrs. She also used every type of itch medicine topically. She also took cortisone 10 plus with lot number 20L317 and expiration date of Oct2023 and diphenhydramine (BENADRYL) which was several times a day, every 4 hours or so. Benadryl works if she keeps herself knocked out otherwise gets bad again. It was also reported that it was exactly not Benadryl but something diphenhydramine 25 mg with lot number P122068 and expiration date is Sep2023. The patient's nerves were on edge because of itching, and she took alprazolam (XANAX) at night for her sleep since she couldn't shut down her itching. It was reported that nothing really helped the itch, unless she takes it every 4 hrs and reported that the medication was helping her. The last stuff doctor prescribed was levocetirizine (XYZAL) which was helping, and her redness was reduced and not intense as earlier. These events resulted in physician's office visit. It was reported that there was no investigation assessment, and no relevant tests were done. The patient's condition was improving. The patient was just wondering how long she takes these pills and getting this itch. The outcome of all these events was recovering at the time of report. No follow up attempts are possible. No further information is expected.